Quality Systems SME

3 weeks ago

Santa Rosa, United States Softworld Inc Full time

Job Title: Quality Systems SME - Quality Integration Project Manager

Location: Santa Rosa CA (Hybrid Role,2-3 Days onsite)

Onsite Requirements:

Solid understanding of ICH 13485 standards
Experience leading Quality System Integration
Global, Medical Device experience

Job Description:
Role profile:


Responsible for leading cross functional activities in the achievement of project objectives through management of Quality & Compliance activities.
Develops project scope and objectives. Establishes and tracks critical milestones, timelines, and contingency plans.
Follows up throughout project process to ensure project goals are achieved. Collaborates with personnel to ensure effective management of project deliverables.
Gathers data to formulate project plan and objectives. Manages project team activities during project implementation.
Directs communication of project status, milestones, timelines, and budget to management.

Main responsibilities include:

Issue and Risk escalation, of impactful issues within the project elements.
Develop project / program budgets and updates based on sound rationales and track routinely.
Create Capital Asset Requests (CAR) where appropriate.
Define impact to the business, attaining buy in from stakeholders/ customers.
Communicate effectively within the team and externally.
Present project status, plans, issues, and recommendations to senior management.
Support or conduct project, technical and financial reviews.
Facilitate decision making through the development of robust proposals.
Negotiate and implement plans, deliverables and priorities with key internal and external stakeholders.
Apply standard project management applications/tools and processes.
Prioritize and track the aspects of several projects including the integrated project plans, budgets, and resources.
Utilize Process Excellence to ensure successful delivery of objectives and tasks.
Identify interdependencies and ensure connections between project elements.
Lead and serve as the primary contact for cross-functional project teams, external alliances and senior management.

Essential skills criteria:

Significant understanding of ICH 13485 guidelines
Significant understanding of 21 CFR 820 compliance
Experience leading Quality System Integration
Significant experience managing resources within a global organization, preferably in a medical devices and diagnostics environment.

Proven success in:


CAPA / Investigations & Deviations
Developing functional strategic plans in alignment with the corporate strategic goals
Leading and developing high performing cross functional & matrix teams.
Building interdependent partnerships to optimize value proposition with limited authority.
Outstanding communication skills which enable strong collaboration and partnering both internally and externally
Ability to successfully lead without authority in ambiguous and complex environment.
Big picture orientation with attention to detail, complemented by a "hands-on" operational and business planning orientation.

Desirable skills criteria:


Demonstrated experience leading strategically significant projects.
Multi-functional experience, including Project Management, RA, QA, R&D, Operations and Customer Services, FDA regulatory experience and statistical analysis.
Process excellence/six sigma/design excellence experience and certifications highly desirable.
PMP / ASQ / CQA Certification
Experience document control for Cardiovascular and/or Orthopaedic devices.
Experience tracking documentation with Track Wise and/or Veeva Vault

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